Question

Phase 1 (clinical trial)

A) Safety and dosage testing in healthy volunteers
B) Randomized controlled trials in a small patient population
C) Large-scale studies in diverse patient groups
D) Post-marketing surveillance and monitoring

Answer 1

Phase I clinical trials focus on safety, tolerability, and pharmacokinetics to establish a safe dosage for a new drug. If the drug shows poor tolerability or pharmacokinetics, it may be dropped from development. The safe dosage range identified in phase I is crucial for proceeding to further trial phases.

Step-by-step explanation:

Understanding Phase I Clinical Trials

The primary goal of phase I clinical trials is to determine whether a new compound is safe and well-tolerated when administered to humans. These trials are vital for establishing the pharmacokinetic properties of the drug, which include absorption, distribution, metabolism, and excretion. An important aspect of this phase is to set an appropriate dosage by conducting single sub-therapeutic dose studies that are gradually escalated, and multiple dose studies. If a drug shows poor tolerability or undesirable pharmacokinetic properties, such as a too long or too short elimination half-life or poor bioavailability, it may be discontinued from further development.

During phase I, researchers closely monitor participants to define the safe dosage range, which is crucial for moving the compound to the next phase of development. The pharmacokinetic evaluation is fundamental in understanding how the body processes the medication, making adjustments to the dosage as necessary based on the results.

Overall, phase I clinical trials are a cornerstone of drug development, ensuring that only compounds with a favorable safety and pharmacokinetic profile proceed to subsequent trial phases.